VALCHLOR® (mechlorethamine) gel is an alkylating drug indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF‑CTCL) in patients who have received prior skin-directed therapy

Proven efficacy in treating patients with Stage IA and IB MF-CTCL, as shown in a 12-month study1

A CAILS score is obtained by adding the severity score of each of the following categories for 5 index lesions: erythema, scaling, plaque elevation, and surface area. A response was defined as a ≥50% reduction from baseline CAILS score, which was confirmed at the next visit at least 4 weeks later. A complete response was defined as a confirmed CAILS score of 0 (none).

The SWAT score is derived by measuring each involved area as a percentage of total body surface area (% BSA) and multiplying it by a severity weighting factor (1=patch, 2=plaque, 3=tumor or ulcer). A response was defined as a ≥50% reduction from baseline in SWAT score, which was confirmed at the next visit at least 4 weeks later.

Comparable SWAT response to compounded nitrogen mustard1

Study design: The efficacy of VALCHLOR was assessed in a randomized, multicenter, observer-blind, non-inferiority trial of 260 patients. Patients were stratified based on Stage (IA vs IB and IIA) and then randomized to receive VALCHLOR gel 0.016% w/w of mechlorethamine (equivalent to 0.02% mechlorethamine HCl) or Aquaphor®-based mechlorethamine HCl 0.02% ointment (compounded mechlorethamine). Patients had received at least one prior skin-directed therapy. Qualifying prior therapies included topical corticosteroids, phototherapy, Targretin® gel, and topical nitrogen mustard. Patients were not required to be refractory to or intolerant of prior therapies. Treatments were applied topically on a daily basis for 12 months. Please note that while Stage IIA patients were included in the trial population, VALCHLOR is only indicated for Stage IA and IB MF‑CTCL.1

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine.

WARNINGS AND PRECAUTIONS

Mucosal or eye injury:
Exposure of mucous membranes to mechlorethamine such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe. Exposure of the eyes causes pain, burns, inflammation, photophobia, and blurred vision. Blindness and severe irreversible anterior eye injury may occur. Should eye exposure or mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation

Secondary exposure:
Avoid direct skin contact with VALCHLOR in individuals other than the patients due to risk of dermatitis, mucosal injury, and secondary cancers

Non-melanoma skin cancer:
Monitor patients during and after treatment with VALCHLOR

Embryo-fetal toxicity:
Women should avoid becoming pregnant while using VALCHLOR due to the potential hazard to the fetus. For nursing mothers, discontinue use of VALCHLOR or nursing

Flammable gel:
VALCHLOR is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has dried

ADVERSE REACTIONS

The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and hyperpigmentation (5%). These reactions may be moderately severe or severe. Elderly patients aged 65 and older may be more susceptible. Depending on severity, treatment reduction, suspension, or discontinuation may be required.

DOSING AND APPLICATION

VALCHLOR is for topical dermatologic use only. Apply a thin film of gel once daily to affected areas of the skin. VALCHLOR is a cytotoxic drug and special handling and disposal procedures should be followed during use. Caregivers must wear disposable nitrile gloves when applying VALCHLOR. Patients and caregivers must wash hands thoroughly after handling or applying VALCHLOR.